跳至主要内容
临床试验/NCT01840670
NCT01840670Unknown不适用

Influence of Central Venous and Abdominal Pressures on the Inferior Vena Cava Shape and Size

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
16
试验地点
1
主要终点
The eccentricity of inferior vena cava transverse sections

研究概览

简要总结

The elliptic shape of inferior vena cava (IVC) sections, while hindering the ultrasound measurement of IVC diameter, may provide a useful tool to estimate central venous pressure (CVP). Hypothetically, the higher is CVP and more the ratio R between minimum and maximum diameters approximates 1. The purpose of this study is to determine R values in four different sections before and after a fluid load test, in order to evaluate if R is affected by the test and at which level the variation is larger.

The secondary endpoint is to search for the parameter best predictive of the positivity of the fluid load test among IVC minimum and maximum diameters, eccentricity, section area, and blood velocity at the level that presented the largest variations after the fluid load.

详细描述

The study will be carried out during the first 6 hours after the end of cardiac surgery when patients are mechanically ventilated and sedated with propofol and remifentanil to achieve a Ramsey sedation score of 3-4. The following four steps will be carried out:

A) A baseline hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.

B) The measurement of abdominal pressure with the head of the bed placed in a horizontal position for 3 minutes.

C) A rapid fluid load test with the head of the bed raised again to be 30°. The test will be performed by infusing 250-300 mL/m2 Body Surface Area of 6% hydroxyethyl starch 6% 130/0.4 (VoluvenR) in 30 minutes and will be considered positive if the cardiac index increases by at least 15% above the baseline value.

D) A second hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the need determined by the attending physician to perform a rapid fluid load test to guide infusions
  • a condition of adequate sedation and good adaptation to mechanical ventilation
  • the presence of an arterial catheter and a catheter in the pulmonary artery

排除标准

  • obesity (BMI> 30 kg/m2)
  • age <18 years
  • women of childbearing age
  • tricuspid insufficiency
  • hemodynamically significant right ventricular failure
  • bleeding from the surgical drains greater than 150 mL in the hour preceding the enrollment
  • history of allergy to colloids
  • administration of more than 1000 mL of hydroxyethyl starch in the last 24 hours

结局指标

主要结局

The eccentricity of inferior vena cava transverse sections

时间窗: Baseline and after forty minutes

The ratio R between the minimum and maximum diameters of inferior vena cava transverse sections at four different levels

次要结局

  • Blood velocity(Baseline and after forty minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Franco Cavaliere

Professor

Catholic University of the Sacred Heart

研究点 (1)

Loading locations...

相似试验